Solid TumorPhase 1NCT05943041
Live Biotherapeutic Product GB104 Phase 1 Study in Colorectal Cancer
A Phase 1 study testing GB104(Level 1), GB104(Level 2) and GB104(Level 3) in people with Solid Tumor and Colorectal Cancer, run by GILongevity at 1 site in South Korea.
Trial summary
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer
- What is being tested?
- GB104(Level 1), GB104(Level 2) and GB104(Level 3)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Apr 2023to 22 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who sign on an informed consent form willingly
- Subjects who have histological and radiological diagnosis of colorectal cancer
- Males and females aged between 19 and 80 years at the time of screening
- Subjects who have undergone radical colectomy and received the following treatments before participating in the clinical trial, and have completed the specified period:
- Subjects who have received adjuvant chemotherapy, radiotherapy, or concurrent chemoradiotherapy and have completed 3 months since the last treatments
- Subjects who have not received any adjuvant therapy and have completed 3 months from the radical colectomy
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- Subjects who have undergone stoma closure and have completed 3 months after stoma closure
- Subjects who have received standard treatment for colorectal cancer without disease progression or recurrence until the first administration of GB104
- Subjects who have received adjuvant chemotherapy or radiation therapy, and have completed 3 months after completing the treatment, and toxicity from previous adjuvant treatment must have recovered to NCI-CTCAE v5.0 grade 1
- Subjects who have been confirmed to have adequate hematological, renal, and hepatic function at the screening point (laboratory tests may be retested during the screening period)
- Female subjects of childbearing potential and sexually active men who agree to abstain from sexual activity or use an adequate method of contraception
Who cannot join
- Significant cardiac dysfunction, New York Heart Association classification for chronic heart failure III-IV, symptomatic coronary artery disease, significant deep vein thrombosis; myocardial infarction within 6 months
- Severe active infections that require systemic antibiotics, antifungal agents, antiviral agents, or other medications that cannot be controlled
- Previous history of immunosuppressant within the 1 month of initial administration
- Known HIV infection, or active infection with hepatitis B or C
- Subjects who have completed a course of antibiotics within the one month prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label, Single-center, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety and Tolerability of GB104, and Explore Gut Microbial Composition in Patients Who Completed Curative Colectomy and Planned Therapy of Colorectal Cancer
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
Read the detailed description
This is a single center, open-label, phase 1 study to evaluate the safety and tolerability of GB104 and explore gut microbial composition in patients with colorectal cancer who completed standard treatment including curative colectomy with or without full-cycle adjuvant chemotherapy. GB104 is a live biotherapeutic product consisting of a lyophilized formulation of a single strain of bacterium. The dosing regimen for the study involves the oral administration of the experimental drug once a day.
- Conditions
- Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer, Rectosigmoid Junction Cancer, Cancer, Rectal Cancer
- Being tested
- GB104(Level 1), GB104(Level 2), GB104(Level 3)
- Medical subject headings
- Colorectal Neoplasms, Sigmoid Neoplasms, Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB104(Level 1)Drug
One capsule QD oral administration for 28 days
GB104(Level 2)Drug
Three capsules QD oral administration for 28 days
GB104(Level 3)Drug
Five capsules QD oral administration for 28 days
| Study group | Role | What they receive |
|---|---|---|
| GB104: Dose level 1 | Experimental | Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels. Receives: Drug: GB104(Level 1) |
| GB104: Dose level 2 | Experimental | Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels. Receives: Drug: GB104(Level 2) |
| GB104: Dose level 3 | Experimental | Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels. Receives: Drug: GB104(Level 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT(Dose-Limiting Toxicity) at week 4
Measured: 4 weeks
Incidence of Adverse Events from baseline to 8 weeks
Measured: assessed up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start28 Apr 2023
- Primary completion22 Dec 2023
- Study completion22 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Sequential Group Assignment (3+3 model)
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- GILongevity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Woo Yong Lee, M.D., Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943041
- Sponsor's protocol ID
- GB-X01-101
- Status last verified
- Feb 2025
- First submitted
- 22 Jun 2023
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Single-center, Dose-escalation Phase 1 Clinical Study to Evaluate the Safety and Tolerability of GB104, and Explore Gut Microbial Composition in Patients Who Completed Curative Colectomy and Planned Therapy of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT05943041
- Acronym / sponsor ID
- GB-X01-101
- Conditions
- Solid Tumor, Colorectal Cancer, Sigmoid Colon Cancer, Rectosigmoid Junction Cancer, Cancer, Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- GILongevityIndustry (pharma, biotech, devices)
- Study start
- 28 Apr 2023 (actual)
- Primary completion
- 22 Dec 2023 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, open label, multi-dose, sequential dose escalation, single-center, Phase 1 trial
Detailed description
This is a single center, open-label, phase 1 study to evaluate the safety and tolerability of GB104 and explore gut microbial composition in patients with colorectal cancer who completed standard treatment including curative colectomy with or without full-cycle adjuvant chemotherapy. GB104 is a live biotherapeutic product consisting of a lyophilized formulation of a single strain of bacterium. The dosing regimen for the study involves the oral administration of the experimental drug once a day.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Sequential Group Assignment (3+3 model)
| Arm | Type | Receives |
|---|---|---|
| GB104: Dose level 1 | Experimental | Drug: GB104(Level 1)Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels. |
| GB104: Dose level 2 | Experimental | Drug: GB104(Level 2)Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels. |
| GB104: Dose level 3 | Experimental | Drug: GB104(Level 3)Dose escalation cohort includes patients with CRC who completed curative colectomy and planned therapy. 3 to 6 patients will be enrolled per escalating dose levels. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects who sign on an informed consent form willingly
- Subjects who have histological and radiological diagnosis of colorectal cancer
- Males and females aged between 19 and 80 years at the time of screening
- Subjects who have undergone radical colectomy and received the following treatments before participating in the clinical trial, and have completed the specified period:
- Subjects who have received standard treatment for colorectal cancer without disease progression or recurrence until the first administration of GB104
Key exclusion criteria (5 listed)
- Significant cardiac dysfunction, New York Heart Association classification for chronic heart failure III-IV, symptomatic coronary artery disease, significant deep vein thrombosis; myocardial infarction within 6 months
- Severe active infections that require systemic antibiotics, antifungal agents, antiviral agents, or other medications that cannot be controlled
- Previous history of immunosuppressant within the 1 month of initial administration
- Known HIV infection, or active infection with hepatitis B or C
- Subjects who have completed a course of antibiotics within the one month prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GB104(Level 1)One capsule QD oral administration for 28 days | Drug | GB104: Dose level 1 |
| GB104(Level 2)Three capsules QD oral administration for 28 days | Drug | GB104: Dose level 2 |
| GB104(Level 3)Five capsules QD oral administration for 28 days | Drug | GB104: Dose level 3 |
Primary outcome
Incidence of DLT(Dose-Limiting Toxicity) at week 4
Time frame: 4 weeks
Incidence of Adverse Events from baseline to 8 weeks
Time frame: assessed up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Woo Yong Lee, M.D., Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB104(Level 1), GB104(Level 2) and GB104(Level 3) in people with Solid Tumor and Colorectal Cancer, run by GILongevity at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT(Dose-Limiting Toxicity) at week 4 (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.